Memorandum by the Prescription Medicines
Code of Practice Authority (PI 128)
RESPONSE TO THE ANALYSIS OF THE PHARMACEUTICAL
INDUSTRY'S MARKETING DOCUMENTS
The Analysis of the Pharmaceutical Industry's
Marketing Documents provided to the House of Commons Health Select
Committee refers to examples which the authors consider contravene
the Association of the British Pharmaceutical Industry (ABPI)
Code of Practice for the Pharmaceutical Industry.
The Prescription Medicines Code of Practice
Authority (PMCPA) has not seen the materials submitted by the
five companies, much of which was internal documentation not for
use with either health professionals or the public. The Code applies
to the promotion of medicines for prescribing to health professionals
and to appropriate administrative staff and to information made
available to the public about medicines so promoted (Clause 1.1).
Internal documentation is not usually covered by the Code. It
appears that much of the material criticised is internal documentation.
The PMCPA does not know whether the materials
requested have already been the subject of complaints under the
Code. It appears from the limited details in the Analysis that
some of the criticisms may relate to matters previously the subject
of complaints under the Code. Most of the products listed have
been the subject of complaints over the last couple of years,
with some ruled to be in breach of the Code. In every case where
a breach is ruled the practice in question has to cease forthwith
and a detailed report is published.
The Analysis draws unsubstantiated conclusions
from activities and misunderstands the requirements of the Code
in that it gives the impression that every activity that increases
sales of a specific medicine is a breach of the Code. This is
simply not so.
When considering whether or not there has been
a breach of the Code the most important considerations are the
content of the material actually used with the health professional
or member of the public and its effect. As in the interpretation
of UK law, the intention of the material/activity is not necessarily
relevant although it might be taken into account when trying to
decide whether high standards have been maintained (Clause 9.1)
or whether there is a reduction in confidence in the industry
(Clause 2) or when determining the sanctions to be applied if
a breach of the Code is ruled.
It appears from the Analysis that there have
been many misunderstandings about what is permitted by the Code
and what is not. Detailed comments appear below.
A. GENERAL PUBLIC
Medicines can be named in information made available
to the public provided such material complies with Clause 20 of
the Code including the prohibition on advertising prescription
only medicines and certain other medicines to the public.
1. It is not a breach of the Code to target
members of the public (even those that are likely to respond to
the message) nor is it a breach of the Code to segment the population.
The important point is whether the materials used with the public
are in accordance with Clause 20 of the Code.
2. It is not a breach of the Code for a
company to carry out its activities in such a way that the public
is more receptive to the message, for example by working with
patient organisations to produce materials or leaving leaflets
in pharmacies and/or surgeries. The content of the material is
the important factor, including the requirement to clearly declare
sponsorship on materials relating to medicines and their uses
3. Companies may make reference to direct
to consumer advertising as some medicines which are promoted to
health professionals for prescribing can also be legally advertised
to the public for purchase (over-the-counter medicines). Public
relations activities to the public are covered by Clause 20. Placing
articles in the lay press, TV documentaries, soap operas etc is
not necessarily in breach of the Code. This would depend on whether
the material provided by the company to the press, TV company
etc complied with the Code.
4. It is not necessarily a breach of the
Code to run advertising campaigns in the national press; this
would depend on the content. A legitimate disease awareness campaign
might be referred to by a company as advertising even though it
does not mention directly or indirectly any medicine at all.
5. Aiming a campaign at those most likely
to take action does not in itself suggest that the campaign is
primarily concerned with those who are most likely to benefit
6. A legitimate disease awareness campaign
that was in accordance with the Code (which would mean it was
also in accordance with the Medicines and Healthcare products
Regulatory Agency guidance) would be acceptable even though it
resulted in increased prescription of the company's product.
7. If material for the public complies with
Clauses 20.1 and 20.2 of the Code, including the need for it to
be factual, balanced information that is not going to raise unfounded
hopes of successful treatment or be misleading with respect to
the safely of the medicine and for it not to encourage members
of the public to ask their doctors to prescribe a specific medicine,
then the use of "emotional" messages is not in conflict
with the requirements of Clause 20 of the Code.
B. HEALTH PROFESSIONALS
The Analysis does not mention the requirements
of Clauses 7.4 and 7.5 that all information claims or comparisons
must be capable of substantiation and that such substantiation
must be provided without delay following a request from a health
professional or appropriate administrative staff. Nor does it
mention that the promotion of a medicine prior to the grant of
the marketing authorisation is prohibited by Clause 3.
1. If promotion to health professionals
and appropriate administrative staff complies with the Code then
the use of "emotional" messages is not a breach of the
2. Companies can provide certain information
prior to the grant of the marketing authorisation provided the
information is not promotional for that medicine.
3. A message to health professionals, appropriate
administrative staff or patients that a medicine is "safe"
would be a breach of the Code (Clauses 7.9 and 20.2). Information
about side effects that reflects available evidence and is capable
of substantiation can be provided.
4. Companies can prepare responses to media
enquiries. Such responses must comply with the Code.
5. Companies have been ruled in breach of
Clause 9.3 for using health professionals to advertise medicines.
Companies can use key opinion leaders to present at meetings etc.
The involvement of the pharmaceutical company should be made clear
and messages from key opinion leaders employed by companies are
subject to the Code. Honoraria payments for health professionals
should be in line with BMA suggested rates or similar.
The only bodies that can decide whether material
or activities are in breach of the Code are the Code of Practice
Panel and the Code of Practice Appeal Board. Bearing in mind the
above comments if details of the specific criticisms were provided
to the PMCPA, then the matters could be dealt with as complaints
under the Code.
The Code is reviewed approximately every two
to three years. The ABPI is currently undertaking a review of
the Code and its operation including consultation with stakeholders